Assessment of quality of life during long-term treatment of tolvaptan in refractory heart failure: design and rationale of the AQUA-TLV study

  • Imamura T
  • Kinugawa K
  • Ohtani T
 et al. 
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The vasopressin type 2 receptor antagonist tolvaptan (TLV) has recently become available to treat congestion in in-hospital patients with heart failure (HF). However, there is no evidence confirming the long-term efficacy of TLV. The Assessment of Quality of life during long-term treatment of TLV in refractory heart failure (AQUA-TLV) study is a multicenter, open-labeled, randomized, controlled clinical trial that will enroll 100 patients from 18 hospitals in Japan. Patients with HF assigned to New York Heart Association class III or IV, who had a previous history of hospitalization due to congestive HF during the past 1 year and ongoing symptomatic congestion with baseline urine osmolality > 350 mOsm/L regardless of being prescribed daily furosemide > 60 mg are randomized to the conventional diuretics group (50 patients) and TLV add-on group (50 patients), and their quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire after 6 months of treatment. This study is the first multicenter prospective randomized study in Japan to evaluate the long-term clinical effectiveness of TLV compared with conventional treatment in patients with congestive HF (UMIN Clinical Trial Registry Number: UMIN 000009604).

Author-supplied keywords

  • *Benzazepines/ad [Administration & Dosage]
  • *Heart Failure/dt [Drug Therapy]
  • *Quality of Life
  • 0 (Antidiuretic Hormone Receptor Antagonists)
  • 0 (Benzazepines)
  • 21G72T1950 (tolvaptan)
  • Aged
  • Aged[checkword]
  • Antidiuretic Hormone Receptor Antagonists
  • Benzazepines [administration & dosage]
  • Dose-Response Relationship
  • Drug
  • Female
  • Female[checkword]
  • Follow-Up Studies
  • Heart Failure [drug therapy] [psychology]
  • Heart Failure/px [Psychology]
  • Hospitalization [trends]
  • Hospitalization/td [Trends]
  • Humans
  • Humans[checkword]
  • Male
  • Male[checkword]
  • Middle Aged
  • Middle Aged[checkword]
  • Prospective Studies
  • Quality of Life
  • Receptors
  • Time Factors
  • Treatment Outcome
  • Vasopressin [antagonists & inhibitors]
  • article
  • brain natriuretic peptide/ec [Endogenous Compound]
  • cardiomegaly
  • clinical assessment
  • controlled study
  • creatinine/ec [Endogenous Compound]
  • diuretic agent/cm [Drug Comparison]
  • furosemide
  • heart failure/dt [Drug Therapy]
  • hepatomegaly
  • hospitalization
  • human
  • long term care
  • lung congestion
  • major clinical study
  • minnesota living with heart failure questionnaire
  • multicenter study
  • open study
  • peripheral edema
  • potassium/ec [Endogenous Compound]
  • priority journal
  • quality of life
  • questionnaire
  • randomized controlled trial
  • refractory heart failure/dt [Drug Therapy]
  • sodium/ec [Endogenous Compound]
  • thorax radiography
  • tolvaptan/cm [Drug Comparison]
  • tolvaptan/ct [Clinical Trial]
  • tolvaptan/dt [Drug Therapy]
  • transthoracic echocardiography
  • urine osmolality

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  • T Imamura

  • K Kinugawa

  • T Ohtani

  • Y Sakata

  • T Higo

  • S Kinugawa

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